MAUDE Adverse Event Report: STRYKER TRAUMA KIEL NAIL HOLDING SCREW GAMMA3 8X35MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	1320-0090
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Upon completion of investigation, additional information will be provided in a supplemental report.
Event or Problem Description
As reported: "gamma naill got stuck with the nail retaining screw and could no longer be removed.Caretaker clamped a nail in a vice and was able to loosen the connection.Replacement was available (31251200s, lot k0237ec) and procedure was completed manually.Surgical delay of 2 hours not longer.Patient had to get foreign blood due to the duration of the surgery".
Additional Manufacturer Narrative
The reported event could not be confirmed since the alleged failure could not be reproduced.The device inspection revealed the following: the received nail holding screw shows normal signs of usage with no visible damage anywhere in the whole screw.The threads are intact with no obvious deformation.A pre-surgical functional test was performed with the returned nail holding screw, target device and a sample nail.The nail holding screw could be assembled with the target device and could be locked and unlocked with the sample nail without any difficulty.Thus, the reported failure could not be reproduced.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Since the alleged failure could not be reproduced, the failure could not be confirmed and the real root cause could not be determined, but since a product deficiency was not identified, the issue is deemed to be user related.Upon reviewing similar cases in the past, the most likely reason for such jamming of nail with the target device is due to a misaligned assembly of the nail with the nail holding screw, which leads to overlapping of the threads and a subsequent jamming.If any further information is provided, the complaint report will be updated.
Event or Problem Description
As reported: "gamma naill got stuck with the nail retaining screw and could no longer be removed.Caretaker clamped a nail in a vice and was able to loosen the connection.Replacement was available (31251200s lot k0237ec) and procedure was completed manually.Surgical delay of 2 hours not longer.Patient had to get foreign blood due to the duration of the surgery.".

• Brand Name: NAIL HOLDING SCREW GAMMA3 8X35MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): STRYKER TRAUMA KIEL; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• MDR Report Key: 10757217
• Report Number: 0009610622-2020-00616
• Device Sequence Number: 3334016
• Product Code: LXH
• UDI-Device Identifier: 04546540377661
• UDI-Public: 04546540377661
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1320-0090
• Device Catalogue Number: 13200090
• Device Lot Number: K574210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 12/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR